510(k) K050966 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
PIVOT BIPOLAR FEMORAL HEAD
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Jul 7, 2005 |
| Received | Apr 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2014 | Ortho Development Corporation Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY
Product Usage:
Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum Terminated |
KWY | None listed |
| Oct 28, 2009 | Ortho Development Corporation Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head. Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.